Revlimid
These highlights do not include all the information needed to use REVLIMID safely and effectively. See full prescribing information for REVLIMID. REVLIMID (lenalidomide) capsules, for oral useInitial U.S. Approval: 2005
Approved
Approval ID
5fa97bf5-28a2-48f1-8955-f56012d296be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-402
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 2.5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-425
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LENALIDOMIDEActive
Quantity: 25 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-420
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LENALIDOMIDEActive
Quantity: 20 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-410
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 10 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-415
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LENALIDOMIDEActive
Quantity: 15 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Lenalidomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-405
Application NumberNDA021880
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenalidomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT